Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT03444558
Status:
COMPLETED
Last Update Posted:
2018-10-24
First Post:
2017-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Natural Supplement Containing Chlorogenic Acid and Luteolin on Cardio-metabolic Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D047311', 'term': 'Luteolin'}], 'ancestors': [{'id': 'D047309', 'term': 'Flavones'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'double-blind study'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'placebo-controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-23', 'studyFirstSubmitDate': '2017-06-05', 'studyFirstSubmitQcDate': '2018-02-22', 'lastUpdatePostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of natural supplement on metabolic parameters including body weight and Body Mass Index (BMI)', 'timeFrame': 'Change from baseline to 6 months of the supplementation', 'description': 'Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including body weight (kg) and height (m) that will be combined to report BMI in kg/m\\^2.'}, {'measure': 'Effect of natural supplement on metabolic parameters including waist circumference', 'timeFrame': 'Change from baseline to 6 months of the supplementation', 'description': 'Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including waist circumference (cm).'}, {'measure': 'Effect of natural supplement on metabolic parameters including plasma lipids', 'timeFrame': 'Change from baseline to 6 months of the supplementation', 'description': 'Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol HDL-C) (mmol/l), while low-density lipoprotein cholesterol (LDL-C) will be calculated using the Friedewald formula.'}, {'measure': 'Effect of natural supplement on metabolic parameters including glucose metabolism parameters', 'timeFrame': 'Change from baseline to 6 months of the supplementation', 'description': 'Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma glycemia (mmol/l).'}, {'measure': 'Effect of natural supplement on metabolic parameters including plasma insulinemia and HOMA (homeostatic model assessment) index', 'timeFrame': 'Change from baseline to 6 months of the supplementation', 'description': 'Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma insulinemia (pmol/L) that with glycemia will be combined to report HOMA index.'}], 'secondaryOutcomes': [{'measure': 'Effect of natural supplement on cardio-metabolic parameters including plasma cytokines', 'timeFrame': 'Change from baseline to 6 months of the supplementation', 'description': 'Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including plasma cytokines (inflammatory markers and adipokines) (pg/ml), that will be assessed using available enzyme-linked immunosorbent assay (ELISA) kits.'}, {'measure': 'Effect of natural supplement on cardio-metabolic parameters including plasma lipoproteins', 'timeFrame': 'Change from baseline to 6 months of the supplementation', 'description': 'Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including atherogenic lipoproteins as well as the analysis of the full spectrum of lipoprotein subclasses by gel electrophoresis.'}, {'measure': 'Effect of natural supplement on cardio-metabolic parameters including subclinical atherosclerosis', 'timeFrame': 'Change from baseline to 6 months of the supplementation', 'description': 'Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including subclinical atherosclerosis assessed by carotid intima-media thickness (CIMT) (mm).'}, {'measure': 'Effect of natural supplement on cardio-metabolic parameters including fatty liver index', 'timeFrame': 'Change from baseline to 6 months of the supplementation', 'description': 'Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including fatty liver index, a noninvasive method used for steatosis detection and quantification.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['metabolic parameters', 'cardio-metabolic parameters'], 'conditions': ['Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '19805654', 'type': 'BACKGROUND', 'citation': 'Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.'}]}, 'descriptionModule': {'briefSummary': 'Clinical trial about beneficial effects of natural ingredient containing chlorogenic acid and luteolin on liver health and conditions related to liver (such as metabolic syndrome) for general body health.', 'detailedDescription': 'This is one randomized, double-blind, placebo-controlled study. The purpose of the present study is to evaluate and/or elucidate the role of the natural supplement, containing chlorogenic acid (10-12%) and luteinyl-7-glucoside (2-4%), on cardio-metabolic risk factors.\n\nThe research hypothesis is to evaluate whether natural supplement containing chlorogenic acid and luteolin (Puraltilix, BIONAP SRL, Catania, Italy) may improve several cardio-metabolic parameters in subjects with the metabolic syndrome.\n\nAll subjects will be evaluated at baseline and after 6 months of treatment (with natural supplement or placebo).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged \\>18 years with the metabolic syndrome (as defined by the international criteria: Alberti KG, et al. Circulation. 2009; 120: 1640-5);\n* BMI\\> 25 kg/m\\^2;\n* Subjects able to swallow whole tablets;\n* Informed consent obtained prior to any study-related activities.\n\nExclusion Criteria:\n\n* Pregnancy or willingness to become pregnant;\n* Severe liver dysfunction (ALT \\>2.5 times upper limit of normal);\n* Severe renal failure (eGFR\\<60 mL/min/1.73 m2 using the MDRD formula);\n* Severe infections at the discretion of the investigator (such as HIV, HBV and HCV);\n* History or presence of malignant neoplasms within the last 5 years.'}, 'identificationModule': {'nctId': 'NCT03444558', 'briefTitle': 'Effects of Natural Supplement Containing Chlorogenic Acid and Luteolin on Cardio-metabolic Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'University of Palermo'}, 'officialTitle': 'Effect of a Natural Supplement Containing Chlorogenic Acid and Luteolin on Cardio-metabolic Risk Factors in Patients With Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'Natural Supplement'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dietary Supplement', 'description': '50 subjects with the metabolic syndrome receiving natural supplement containing chlorogenic acid and luteolin (450 mg/die)', 'interventionNames': ['Dietary Supplement: Natural supplement containing chlorogenic acid and luteolin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '50 subjects with the metabolic syndrome receiving placebo (without any active ingredients)', 'interventionNames': ['Other: Placebo (without any active ingredients)']}], 'interventions': [{'name': 'Natural supplement containing chlorogenic acid and luteolin', 'type': 'DIETARY_SUPPLEMENT', 'description': '50 eligible subjects will receive natural supplement as the oral pills at a fixed dose of 1 pill/day (450 mg/day) for 6 months, as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study.', 'armGroupLabels': ['Dietary Supplement']}, {'name': 'Placebo (without any active ingredients)', 'type': 'OTHER', 'description': '50 eligible subjects will receive placebo (without any active ingredients) at a fixed dose of 1 pill/day for 6 months, as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90127', 'city': 'Palermo', 'state': 'Palrmo', 'country': 'Italy', 'facility': 'University Hospital of Palermo', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}], 'overallOfficials': [{'name': 'Manfredi Rizzo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Palermo, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Palermo', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Catania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Associate Professor', 'investigatorFullName': 'Manfredi Rizzo', 'investigatorAffiliation': 'University of Palermo'}}}}